Quality Investigations Lead

Bristol-Myers Squibb Co; New Jersey; On-site; USD 94,000 - 114,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible time off

Holiday schedule

Job summary

Bristol Myers Squibb is seeking a quality investigations professional in Summit West, NJ. The role focuses on reviewing complex CAPAs, deviations, and risk assessments across manufacturing and lab systems to ensure robust corrective actions and regulatory compliance.

You will coach staff, support inspections, and drive continuous improvement while maintaining quality culture and timely disposition of issues.

Qualifications

• Bachelor's degree in STEM field preferred.
• High school diploma/Associates with eq. combination may be considered.
• 6+ years of experience in a regulated industry, preferably with 2+ year of deviation experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated proficiency in root cause analysis tools including 5-WHY, IS/IS-NOT, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc.

Responsibilities

• Review and approve complex investigations/ CAPAs / effectiveness checks across manufacturing processes.
• Author, review, approve technical reports including risk assessments and deviation monitoring.
• Ensure corrective/ preventive actions address root cause and are robust.
• May perform routine reporting and analysis of metrics to close quality events on time.
• Lead deviation processes and coach staff in investigations and root cause analysis.
• Support internal/external inspections and present topics during audits.

Job description

Bristol Myers Squibb is seeking a quality investigations professional in Summit West, NJ. The role focuses on reviewing complex CAPAs, deviations, and risk assessments across manufacturing and lab systems to ensure robust corrective actions and regulatory compliance.

You will coach staff, support inspections, and drive continuous improvement while maintaining quality culture and timely disposition of issues.